Lupus is the prototypical autoimmune disease which causes inflammation to various parts of the body, including major organs such as the kidneys. Approximately 1.5 million Americans have a form of lupus, mostly women. Lupus is more common among people of color, and African Americans have a higher rate of lupus kidney disease than do Caucasians. The exact reasons for this disparity are not know, but researchers have identified a gene associated with increased risk of lupus kidney disease in African Americans.

The immune system normally produces antibodies, or proteins, which protect the body from foreign invaders, such as viruses or bacteria. In people with lupus, the immune system produces abnormal antibodies, called autoantibodies, which form immune complexes that lodge in various tissues. Lupus nephritis occurs when autoantibodies form or are deposited in kidney tissue, causing inflammation and preventing the kidneys from functioning properly. Some people with lupus nephritis may have complete loss of kidney function. If this happens, a patient may need to go on dialysis or even need a kidney transplant.

Many advances have been made in treating kidney disease and, if caught early, treatment usually is effective. Medicines can decrease this inflammation. The most common medicines used are corticosteroids (which decrease inflammation) and cytotoxic or immunosuppressive drugs (which suppress the activity of the immune system).

Unfortunately, current treatments are toxic and can cause other serious health problems. No new drugs have been approved to treat lupus is nearly 40 years. However, several promising new therapies are undergoing clinical study or awaiting approval by the U.S. Food and Drug Administration.

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The new botulism vaccine offers for the first time a viable means of providing an effective deterrent against bioterrorist attack. As it is very similar to the tetanus toxoid mass vaccination of the entire population would be feasible. Alternatively first responders to an outbreak, such as paramedics or firefighters, can be immunised and the outbreak contained.

Cambridge Biostability will be working in collaboration with DVC LLC, which is organising the production of seven different toxoids, altering the gene in each to make the poison antigenic but not toxic. As each vaccine emerges the technology to stabilise it will also be applied.

Principal Investigator Dr Ian Henderson, Ph.D DVC LLC says that the new technology is a major breakthrough: Each serotype of botulinum neurotoxin requires its own vaccine to provide protection. This means that to cover all possibilities of combating botulism, both natural and man-made, a single vaccine formulation should contain all seven vaccine antigens, each optimally formulated to maximize protection and stability. The new technology developed by Cambridge Biostability Ltd. has the potential to make such a goal a reality, combining potent vaccine formulations with long term high temperature stability characteristics, with the prospect of eliminating the cold chain.

Dr Roser sees the partnership with DVC LLC as the first important phase in a long-term programme culminating in the production, development, scale-up and manufacture of a maximally stable and potent botulinum vaccine. Cambridge Biostability also intends to make its technology available for the development of stable liquid versions of the other vaccines in the Biodefense Initiative. The stable liquid format is ideal for stockpiling vaccines in an instantly injectable form without the need for refrigeration.

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